The US Food and Drug Administration approved updated COVID-19 booster vaccines from Pfizer-BioNTech and Moderna on Friday, clearing the reformulated shots for the 2026-27 respiratory virus season. The decision followed an FDA advisory committee endorsement earlier in the week.
The approvals came with narrower labeling than in previous years, emphasizing use in adults aged 65 and older and younger people with underlying medical conditions. The reformulated vaccines target currently circulating Omicron-descendant strains identified by the agency's strain-selection process over the summer.
The Centers for Disease Control and Prevention was expected to finalize accompanying clinical recommendations shortly after the FDA action, determining which groups insurers and pharmacies would cover without cost. Pharmacy chains including CVS and Walgreens have prepared to begin administering doses within days of sign-off.
Public health physicians and pharmacists urged eligible Americans, particularly seniors and immunocompromised patients, to schedule shots ahead of the autumn wave alongside seasonal flu vaccination. The rollout arrives as several US states report rising respiratory illness activity heading into cooler months.
Manufacturers said supplies of the updated formulations were already shipping to distribution centers. Both Pfizer and Moderna confirmed they had scaled production to meet anticipated demand during the fall campaign.